NCT01697787

Brief Summary

This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid Diagnosis Tests (RDTs) compared to the microscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

September 29, 2012

Last Update Submit

July 29, 2015

Conditions

Malaria

Keywords

Treatment, diagnosis

Outcome Measures

Primary Outcomes (1)

  • Rate of treatment failures

    The rate of the two ACTs treatment failures at day 28: all treatment failures, both parasitological and clinical (positive blood slide at day 28)

    28 days

Secondary Outcomes (1)

  • RDT performance Vs microscopy

    28 days

Other Outcomes (2)

  • Fever clearance time (FCT) Fever Clearance Time

    28 days

  • Gametocytes carriage

    28 days

Study Arms (2)

Amodiaquine-Artesunate

OTHER

ASAQ is produced by Sanofi-Aventis as CoarsucamTM and as artesunate-amodiaquine Winthrop®

Drug: Amodiaquine-Artesunate

Artemether-Lumefantrine

OTHER

AL (tablets containing 20 mg of artemether and 120 mg of lumefantrine) is produced by Novartis

Drug: Artemether-lumefantrine

Interventions

Amodiaquine-ArtesunateDRUG

If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.

Also known as: ASAQ Winthrop, Coarsucam
Amodiaquine-Artesunate
Artemether-lumefantrineDRUG

If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.

Also known as: Coartem, Riamet
Artemether-Lumefantrine

Eligibility Criteria

Age6 Months - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 6 months,
  • eight above 5 kg;
  • Positive blood slide (parasitaemia ≥ 2,000/μL to 200,000/μL) with Plasmodium falciparum monospecific infection ;
  • Fever (axillary temperature above 37.5 °C) or history of fever in the preceding 24 hours;
  • Haemoglobin value above or equal 5.0 g/dL
  • Signed informed consent;
  • Willingness and ability to comply with the study protocol for the duration of the trial.

You may not qualify if:

  • Participation in any other investigational drug study (antimalarial or others) during the previous 30 days
  • Known hypersensitivity to the study drugs
  • Severe malaria
  • Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (more than 1 in 24h), unconscious state, unable to sit or stand;
  • Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study.
  • Severe malnutrition (defined as weight for height less than 70% of the median NCHS/WHO reference)
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Reaserch Unit

Nanoro, Boulkiemdé, 218, Burkina Faso

Location

MeSH Terms

Conditions

MalariaDisease

Interventions

amodiaquine, artesunate drug combinationArtemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Halidou Tinto, PharmD, PhD

    IRSS/Centre Muraz

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD, PhD

Study Record Dates

First Submitted

September 29, 2012

First Posted

October 2, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

BU(1)